Cook recalls StoneBreaker Exhaust Caps due to potential inadequate sterilization during reprocessing, affecting all units sold. Consumers should check product details and contact Cook for guidance.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Cook is recalling StoneBreaker Exhaust Caps because they may not be properly sterilized when following reprocessing instructions. This could lead to infections if used in medical settings without adequate sterilization.
The exhaust caps may not reach the required sterility level when reprocessed according to the manufacturer's instructions. This could allow harmful bacteria to remain on the equipment, increasing infection risks during medical procedures.
Healthcare facilities using StoneBreaker Exhaust Caps for medical equipment reprocessing are most at risk. Patients using improperly sterilized equipment could face infection risks.
Check for the catalog number SBA-EC, GPN G52599, or UDI (01)00827002525993 on the product. All lots of this exhaust cap are affected.
Look for the catalog number SBA-EC, GPN G52599, or UDI (01)00827002525993 on the exhaust cap.
This recall applies to StoneBreaker Exhaust Caps used in medical equipment reprocessing. If you have these caps, check the product details.
The recall record does not specify a replacement process or remedy.
The recall does not require immediate discontinuation; users should check product details and contact Cook for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1591-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1591-2018 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
